BEUDAMED
    FDA Recall Open, Classified

    ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187

    Recall: Z-2325-2025 · Initiated July 24, 2025

    Recall

    Recall Number
    Z-2325-2025
    Event Number
    97318
    Firm
    Boston Scientific Corporation
    FEI Number
    2124215
    Product Code
    LWS
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    July 24, 2025
    Posted
    August 20, 2025
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187

    Reason

    Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.

    Action

    On July 24, 2025, firm notified physicians via Important Medical Device Information letters. The letter provides information on the management of gradually rising daily subthreshold, low-voltage shock impedance (LVSI) pattern associated with calcification of expanded polytetrafluoroethylene (ePTFE) coated single coil (SC) and dual coil (DC) RELIANCE defibrillation leads manufactured by Boston Scientific Corporation between 2002 to 2021. Letter includes recommendations for routine follow-ups of affected leads, and considerations to take if lead replacement is planned. The firm is not recommending any changes to the scheduled follow-up interval for patients with ePTFE lead models.

    Distribution

    Worldwide Distribution. US nationwide. International distribution worldwide.

    Quantity

    247,702 US; 344,670 OUS